Popularity over the past few years the medical devices used in illegal situations

Medical devices with a wide variety of applications, when used effectively can ensure that their security is directly related to people's health and safety.

In recent years, the medical device adverse report increasing illegal use of medical devices. As a law enforcement officer, the author of this article for nearly the past few years have seen and heard of violations summary of medical devices, to the readers. Current levels of village clinics, hospitals, dispensaries and community health units, service agencies, the private clinic, family planning, technical services (hereinafter collectively referred to use units) is the main force in the use of medical devices. The investigation found that the relevant personnel attaches great importance to the medical, pharmaceutical, and other professional knowledge of learning, but the medical equipment of the laws, regulations and rules but have little knowledge to better achieve the legitimate use of medical equipment, ensure the safe and effective medical devices, better protection of human health and the safety of life. Unlawful scenario 1: using an expired medical devices

Case: 8 June 2007, law enforcement officers in a hospital warehouse check and found that the warehouse of class I medical devices "disposable film gloves" valid until May 10, 2007.

The hospital medical equipment kudan display: 20 may receive health section 10 above the glove bag. Law enforcement personnel to the health care branch further investigation found that the gloves are already using 6 bags, inventory 4 bags. The present case, the use of gloves has expired. Qualitative: the Act of using outdated equipment in violation of the medical devices regulatory Ordinance article 26, paragraph 3, should be under medical supervision Ordinance article 42. Unlawful scenario 2: use the counterfeiting of medical devices

1. medical equipment specifications, labels or packaging, logos marked production enterprise does not exist.

Case study: the use of medical devices in hospitals "ECG analysis system" certification marks production enterprise to Beijing a pharmaceutical enterprise.

The Health Center offers these instruments registration certificate number: jingyao for prison (prospective) words 02 101185, production enterprise license number: jingyao tube machines production Xu 20000118, certification bodies are: the drug administration in Beijing. But Beijing drug administration investigation, the manufacturer has not obtained the license for medical device manufacturers, Beijing Municipal Administration has never issued registration number is "jingyao for prison (prospective) words 02 101185" registration form.

The equipment for qualitative: unregistered counterfeit products.

The present case, the results of health hospitals use "ECG analysis system" should be classified as using no product registration certificate for medical equipment.

2. medical equipment specifications, labels or packaging, logos marked production enterprises although exists, but not the production of medical devices.

Case study: the use of medical devices in a hospital "WM-ⅱ-Micron light treatment instrument" fuselage label marking production enterprise to Dalian, not shown in a company registration number, medical device manufacturers license number, etc.

By Dalian municipal food and Drug Administration investigation, the production company as legal instruments manufacturing enterprises, but never produced the "WM-ⅱ-Micron light treatment instrument". These products are counterfeit no product registration certificate for medical equipment. Unlawful scenario 3: use a model-wide medical devices

Case study: a dental specialist clinics use of medical devices "FJ22A-name：componding dental equipment" production enterprises: Shanghai medical instruments co., Ltd, specification model: FJ22A type, registration number: Shanghai-drug armed (prospective) Word 2003 first 25500 × × number, date of production: in October 2003.

Investigation, the registration number into the "Shanghai drug armed (prospective) Word 2003 first 25500 × ×" on the registration certificate shall identify the product specifications for FJ22, excluding FJ22A. FJ22A-product registration number as "Shanghai drug armed (tentative) Word 2004 first 20600 × ×", registered for 2004 April 9. Production enterprises in the approved prior to the production of these types of products. Unlawful scenario four: no operating qualification of suppliers purchase medical equipment

1. the supplier is not there, the operating licenses and other documents are fabricated.

Case study: May 10, 2007, law enforcement officers in a hospital found therein by 31 October 2006 with from Hefei into science and technology development co., Ltd. purchased KD580 monitor 4.

These monitors are marking production enterprises label as a company, registered number: jingyao tube armed (prospective) Word 2002 first 22101 × × number (and more). With Hefei city food and Drug Administration verification, Hefei legitimate medical ventures, no with Hefei into science and technology development co., Ltd.; marked with "Hefei into science and technology development co., Ltd." to the medical device business licenses and other documents are forged.

2. the supplier's production or business legally exist, but the units purchased products beyond the supplier's production or business scope.

Case: 28 February 2005, law enforcement officers check finds a clinic use of medical devices "one-time use narcotic analgesic pump" containers with disposable syringe (a pump with a syringe), pain pump and injector production enterprises, respectively, as well as a medical instrument co., Ltd Yangzhou, Jiangsu Yangzhou, a medical equipment factory.

After verification, Yangzhou city, a medical instrument co., Ltd only production "disposable" narcotic analgesic pump does not have the qualification, production and marketing of disposable syringes of qualification. The clinic from Yangzhou purchases a medical instrument co., Ltd has a total of 40 sets of these products have been used to inventory sets of 9 31 series. The present case, the clinic purchases "disposable" narcotic analgesic pump channels do not have problems, but purchases of companion use disposable syringes of channels is illegal. In addition to these four main illegal situations, there is the use of the medical certificateTherapy equipment, usage increase manuals without indications or adapt the scope of medical equipment, etc. In order to effectively prevent counterfeiting, illegal use of medical devices into the unit, eliminate the use of medical equipment violations from occurring, use units of related people should learn about the medical equipment of the laws, regulations and rules, and further enhance legal awareness, improve the identification of counterfeit and illegal medical skills. Specific to the practice, at a minimum, you should do: buy acceptance, according to law normative store medical instruments.